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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 076143

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NDA 076143 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Endo Operations, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Rising, Sandoz, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs, and is included in fifty-eight NDAs. It is available from seventy-two suppliers. Additional details are available on the BUPROPION HYDROCHLORIDE profile page.

The generic ingredient in BUPROPION HYDROCHLORIDE is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 076143

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 076143

Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Suppliers and Packaging for NDA: 076143

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	076143	ANDA	Major Pharmaceuticals	0904-6635	0904-6635-61	100 BLISTER PACK in 1 CARTON (0904-6635-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	076143	ANDA	Major Pharmaceuticals	0904-6636	0904-6636-61	100 BLISTER PACK in 1 CARTON (0904-6636-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Jan 17, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 17, 2006	TE:	AB	RLD:	No

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